Quality Responsibilities Table Clause Samples

Quality Responsibilities Table. The detailed listing of activities associated with manufacture, supply, analysis, and release of Product(s), specifying the respective individual responsibilities of the Parties is attached hereto as appendix 1.

Quality Responsibilities Table. Party 1 = DKSH; Party 2 = CMS; Party 3 = Manufacturer

Quality Responsibilities Table. Unless otherwise indicated, responsibility for each activity is assigned to either PCI, or Customer, or is assigned to both PCI and Customer. 1.01 Follow applicable regulations and current Good Manufacturing Practices, as well as locally imposed requirements. X X 1.02 Package, ship, store and test the Product and materials in an environment meeting the applicable GMP regulations, which is designed, constructed and maintained in a manner that a) permits the operation therein to be performed under clean, sanitary and orderly conditions; b) permits the effective cleaning of all surfaces; and c) prevents the contamination of the Product and the addition of extraneous material to the Product. X 1.03 Maintain a valid facility registration covering the packaging of the Product. X 1.04 Operate in compliance with applicable environmental, occupational health and safety laws and regulations. X 1.05 Notify Customer of requests for information, notices of violations or other communication from a government agency relating to environmental, occupational health and safety compliance that impact the Product. X 1.06 Have management controls in place to track and trend investigations and commitments. X 1.07 Maintain a quality unit that is independent of production that fulfills both quality assurance and quality control responsibilities. X 1.08 Disposition of Product by quality unit or Qualified Person (QP). X X 1.09 Involve the quality unit in all Good Manufacturing Practices related matters. X 1.10 Maintain internal Good Manufacturing Practices audit program. X

Quality Responsibilities Table. Responsibilities Not Applicable BioPharmX UPM

Quality Responsibilities Table. Note: if inconsistencies exist between the text of the Quality Agreement and this table, the text of the Quality Agreement takes precedent. 1.01 Follow applicable regulations and current Good Manufacturing Practices, as well as locally imposed requirements. • 21CFRPart4 • 21CFRPart11 • 21 CFR Parts 210 and 211 • 21 CFR Parts 600, 601 & 610 • Eudralex - Annexes 1 and 13, the Rules Governing Medicinal Products in the European Union, Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. • ICH Q9 - Quality Risk Management • ICH Q10 - Pharmaceutical Quality System • Eudralex - The Rules Governing Medicinal Products in the European Union, Volume 10, Chapter 3 Applicable compendia requirements (e.g. USP, EP), as required by XERIS and PYRAMID agreed to in writing by the Parties [***] [***] Document No: Revision: Revision Date: Replaces: Page: QA-Xeris 00 11/10/16 NA Page 28 of 52 1.02 Manufacture, package, ship, store and test the Product and materials in an environment meeting the applicable cGMP regulations, which is designed, constructed and maintained in a manner that a) permits the operation therein to be performed under clean, sanitary and orderly conditions; b) permits the effective cleaning of all surfaces; and c) prevents the contamination of the Product and the addition of extraneous material to the Product. [***] [***] 1.03 Manufacture the Product in adherence to approved Master Batch Records (MBRs) and product specifications, etc. where applicable. [***] [***] 1.04 Refrain from activity that could adversely affect quality of the Product. [***] [***] 1.05 Have management controls in place to track and trend investigations and corrective or preventative action commitments. [***] [***] 1.06 Maintain a Quality Unit that is independent of production and that fulfills both quality assurance and quality control responsibilities. [***] [***]

Quality Responsibilities Table. Table Key: N = Not Applicable APPENDIX 1: (Contacts and Responsibilities) Sharp Transcept What a Copy to: Supplier Transcept APPENDIX 3: Product Security- Supplier Requirements

Quality Responsibilities Table. Responsibilities Client Supplier

Quality Responsibilities Table. Responsibilities Pfizer Contractor APPENDIX 1: Definition of Product, Materials or Service APPENDIX 2: Contacts and Responsibilities QUALITY ASSURANCE QUALITY ASSURANCE BUSINESS MANAGER BUSINESS MANAGER Contact Person for Notices, including notices of Changes, Assignment, Termination, & Resolution of Quality Issues NOTE: Contractor to inform Pfizer Quality Assurance if changes need to be made to this appendix.

Quality Responsibilities Table. A. Compliance Requirements B. Right to Audit C. Regulatory Inspections and Exchanges D. Regulatory Documentation E. Animal Derived Materials F. Buildings and Facilities G. Personnel and Training H. Sub-Contracting and Testing I. Change Control J. Validation/Qualification K. Preventative Maintenance and Calibration L. Investigations M. Documentation and Records N. Annual Product Reviews O. Annual Product Report (if applicable) P. Production and In-Process Controls, Packaging and Labeling Q. Process Equipment R. Reprocess S. Rework